Delivery system for biological component

Abstract

A controlled release delivery system composition and method for oral administration of a biological component is disclosed. Preferably, a bacterium is delivered, and more preferably the bacterium is probiotic in nature.

1 . A delivery system for a biological component comprising: 
 a delivery vehicle; and    a delivered component, the delivered component including a biologic.    
     
     
         2 . The delivery system of  claim 1  wherein the delivery vehicle is a hydrophilic agent, the hydrophilic agent selected from at least one of the group consisting of a swellable polymer, polysaccharide, polypeptide, resin, and gum.  
     
     
         3 . The delivery system of  claim 1  wherein the delivery vehicle is a hydrophilic agent, the hydrophilic agent selected from at least one of the group consisting of: 
 a) a starch selected from the group consisting of rice, corn or potato starch;    b) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    c) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    d) a polysaccharide selected from the group containing pectin and maltodextrin;    e) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    f) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    g) aluminum hydroxide;    h) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture; and    i) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         4 . The delivery system of  claim 1  or  2  wherein the delivery system is a monolithic tablet  
     
     
         5 . The delivery system of  claim 1  or  2  wherein the delivery system is a capsule.  
     
     
         6 . The delivery system of  claim 1  or  2  wherein the delivery system is an oral delivery system.  
     
     
         7 . The delivery system of  claim 1  or  2  wherein the biologic is at least a bacteria.  
     
     
         8 . The delivery system of  claim 1  wherein the delivery vehicle is a hydrophobic agent, the hydrophobic agent selected from at least one of the group consisting of a wax or other inert material.  
     
     
         9 . The delivery system of  claim 1  wherein the delivery vehicle is a hydrophobic agent, the hydrophobic agent selected from at least one of the group consisting of: 
 a) a wax selected from the group consisting of bees wax and carnuba wax.    
     
     
         10 . The delivery system of  claim 1  or  8  wherein the delivery vehicle is a monolithic tablet  
     
     
         11 . The delivery system of  claim 1  or  8  wherein the delivery system is an oral delivery system.  
     
     
         12 . The delivery system of  claim 1  or  8  wherein the biological component includes at least a bacteria.  
     
     
         13 . A delivery system for a biological component, the system comprising: 
 a delivery vehicle;    a release-modifying agent; and    a delivered component, the delivered component including a biologic, wherein the delivery vehicle is a hydrophilic agent.    
     
     
         14 . The delivery system of  claim 13  wherein the hydrophilic agent is selected from at least one of the group consisting of a swellable polymer, polysaccharide, polypeptide, resin, and gum.  
     
     
         15 . The delivery system of  claim 13  wherein the hydrophilic agent is selected from at least one of the group consisting of: 
 a) a starch selected from the group consisting of rice, corn or potato starch;    b) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    c) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    d) a polysaccharide selected from the group containing pectin and maltodextrin;    e) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    f) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    g) aluminum hydroxide;    h) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture; and    i) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         16 . The delivery system of  claim 13  wherein the release-modifying agent is selected from 
 a) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    b) a polysaccharide selected from the group containing pectin and maltodextrin;    c) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture;    d) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone; and    e) starch selected from the group consisting of rice, corn or potato starch;    f) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    g) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    h) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    i) aluminum hydroxide; and    j) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         17 . The delivery system of  claim 13  wherein the delivery vehicle is a monolithic tablet  
     
     
         18 . The delivery system of  claim 13  wherein the delivery vehicle is a capsule.  
     
     
         19 . The delivery system of  claim 13  wherein the delivery system is an oral delivery system.  
     
     
         20 . The delivery system of  claim 13  wherein the biologic is at least a bacteria.  
     
     
         21 . A delivery system for a biological component wherein the system comprises: a delivery vehicle; 
 a release-modifying agent; and    a delivered component, the delivered component including a biologic, wherein the delivery vehicle is a hydrophobic agent.    
     
     
         22 . The delivery system of  claim 21  wherein the hydrophobic agent is a wax or other inert material.  
     
     
         23 . The delivery system of  claim 21  wherein the hydrophobic agent is a wax, the wax selected from at least one of the group consisting of bees wax and carnuba wax.  
     
     
         24 . The delivery system of  claim 21  wherein the release-modifying agent is a pore-forming excipient selected from at least one of the group consisting of: 
 a) a polysaccharide selected from the group containing pectin and maltodextrin;    b) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    c) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone;    d) a salt selected from the group consisting of sodium, calcium, potassium, or magnesium salts;    e) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan; and    f) starch selected from the group consisting of rice, corn or potato starch.    
     
     
         25 . The delivery system of  claim 21  wherein the delivery vehicle is a monolithic tablet  
     
     
         26 . The delivery system of  claim 21  wherein the delivery system is an oral delivery system.  
     
     
         27 . The delivery system of  claim 21  wherein the biologic includes at least a bacteria.  
     
     
         28 . A delivery system for a biological component wherein the system comprises: 
 a delivery vehicle, the delivery vehicle is a hydrophilic agent;    an electrolytic agent; and    a delivered component, the delivered component including a biologic.    
     
     
         29 . The delivery system of  claim 28  wherein the hydrophilic agent is selected from at least one of the group consisting of a swellable polymer, polysaccharide, polypeptide, resin, and gum.  
     
     
         30 . The delivery system of  claim 28  wherein the hydrophilic agent is selected from at least one of the group consisting of: 
 a) a starch selected from the group consisting of rice, corn or potato starch;    b) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    c) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    d) a polysaccharide selected from the group containing pectin and maltodextrin;    e) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    f) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    g) aluminum hydroxide;    h) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture; and    i) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         31 . The delivery system of  claim 28  wherein the electrolytic agent is selected from at least one of the group consisting of a 
 a) a salt selected from the group containing sodium, calcium, potassium, or magnesium salts;    b) an amino acid; and    c) an ionic compound.    
     
     
         32 . The delivery system of  claim 28  wherein the delivery vehicle is a monolithic tablet  
     
     
         33 . The delivery system of  claim 28  wherein the delivery vehicle is a capsule.  
     
     
         34 . The delivery system of  claim 28  wherein the delivery system is an oral delivery system.  
     
     
         35 . The delivery system of  claim 28  wherein the biological component includes at least a bacteria.  
     
     
         36 . The delivery system of  claim 28  wherein the electrolytic agent is capable of inducing an intra-dosage form pH physiologically acceptable to the reconstitution of a lyophilized bacteria.  
     
     
         37 . A delivery system for a biological component wherein the system comprises: a delivery vehicle, the delivery vehicle is a hydrophobic agent; 
 an electrolytic agent;    a release modifying agent, and    a delivered component, the delivered component including a biologic.    
     
     
         38 . The delivery system of  claim 37  wherein the hydrophobic agent is a wax or other inert material.  
     
     
         39 . The delivery system of  claim 37  wherein the hydrophobic agent is a wax, the wax selected from at least one of the group consisting of bees wax, paraffin, and carnuba wax.  
     
     
         40 . The delivery system of  claim 37  wherein the release-modifying agent is a pore-forming excipient selected from at least one of the group consisting of: 
 a) a polysaccharide selected from the group containing pectin and maltodextrin;    b) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    c) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    d) a salt selected from the group consisting of sodium, calcium, potassium, or magnesium salts;    e) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan; and    f) starch selected from the group consisting of rice, corn or potato starch.    
     
     
         41 . The delivery system of  claim 37  wherein the electrolytic agent is selected from at least one of the group consisting of a 
 a) a salt selected from the group containing sodium, calcium, potassium, or magnesium salts;    b) an amino acid; and    c) an ionic compound.    
     
     
         42 . The delivery system of  claim 37  wherein the delivery vehicle is a monolithic tablet  
     
     
         43 . The delivery system of  claim 37  wherein the delivery system is an oral delivery system.  
     
     
         44 . The delivery system of  claim 37  wherein the biologic includes at least a bacteria.  
     
     
         45 . The delivery system of  claim 37  wherein the electrolytic agent is capable of inducing an intra-dosage form pH physiologically acceptable to the reconstitution of a lyophilized bacteria.  
     
     
         46 . An delivery system comprising: 
 a hydrophilic agent;    an electrolytic agent;    a release-modifying agent; and    an active portion, the active portion including a biological component.    
     
     
         47 . The delivery system of  claim 46  wherein the hydrophilic agent is selected from at least one of the group consisting of a swellable polymer, polysaccharide, polypeptide, resin, and gum.  
     
     
         48 . The delivery system of  claim 46  wherein the hydrophilic agent is selected from at least one of the group consisting of: 
 a) a starch selected from the group consisting of rice, corn or potato starch;    b) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    c) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    d) a polysaccharide selected from the group containing pectin and maltodextrin;    e) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    f) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    g) aluminum hydroxide;    h) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture; and    i) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         49 . The delivery system of  claim 46  wherein the release-modifying agent is selected from 
 a) an algae derivative selected from alginic acid, sodium alginate, agar, dextran and carageenan;    b) a polysaccharide selected from the group containing pectin and maltodextrin;    c) a polypeptide selected from the group consisting of gelatin, collagen, casein or heterogeneous protein mixture;    d) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone; and    e) starch selected from the group consisting of rice, corn or potato starch;    f) a gum selected from the group consisting of tragacanth gum, locust beam gum, acacia gum, guar gum, xanthan gum, ghatti gum, or galactomannan gum;    g) a cellulose derivative selected from the group consisting of methylcellulose, carboxymethylcellulose, sodium starch glycollate, sodium or calcium carboxymethylcellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, ethylhydroxy ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, cellulose acetate phthalate or microcrystalline cellulose;    h) silica, aluminum silicate, magnesium silicate, aluminum magnesium silicate, sodium silicate or felspar;    i) aluminum hydroxide; and    j) a polymer selected from the group consisting of acrylate, carboxypolymethylene, a polyalkylene glycol or polyvinylpyrrolidone.    
     
     
         50 . The delivery system of  claim 46  wherein the electrolytic agent is selected from at least one of the group consisting of a 
 a) a salt selected from the group containing sodium, calcium, potassium, or magnesium salts;    b) an amino acid    c) an ionic compound    
     
     
         51 . The delivery system of  claim 46  wherein the delivery vehicle is a monolithic tablet  
     
     
         52 . The delivery system of  claim 46  wherein the delivery vehicle is a capsule.  
     
     
         53 . The delivery system of  claim 46  wherein the delivery system is an oral delivery system.  
     
     
         54 . The delivery system of  claim 46  wherein the biologic is a bacteria.  
     
     
         55 . The delivery system of  claim 46  wherein the electrolytic agent is capable of inducing an intra-dosage form pH physiologically acceptable to the reconstitution of a lyophilized bacteria.  
     
     
         56 . A pre-dosage form blend of the powders, the blend comprising: 
 about 5% to 40% of an hydrophilic agent by total weight;    about 5% to 40% of a release modifying agent by total weight;    about 1 to 40% of an electrolytic agent by total weight;    and a biological component.    
     
     
         57 . The pre-dosage blend of  claim 56  wherein the pre-dosage blend can be formed into a drug delivery system.  
     
     
         58 . The pre-dosage blend of  claim 57  wherein the drug delivery system is monolithic directly compressed tablet.  
     
     
         59 . The pre-dosage blend of  claim 56  wherein the hydrophilic agent is at least one of a cellulose derivative and galactomannan gum.  
     
     
         60 . The pre-dosage blend of  claim 59  wherein the cellulose derivative is hydroxypropyl methylcellulose.  
     
     
         61 . The pre-dosage blend of  claim 56  wherein the release-modifying agent at least one of the group consisting of polysaccharide and a polypeptide.  
     
     
         62 . The pre-dosage blend of  claim 61  wherein the polysaccharide is pectin.  
     
     
         63 . The pre-dosage blend of  claim 56  wherein the electrolytic agent is selected from at least one of the group consisting of sodium carbonate, sodium biocarbonate, sodium phosphate, and calcium carbonate.  
     
     
         64 . The pre-dosage blend of  claim 56  wherein the biologic is a probiotic.  
     
     
         65 . The pre-dosage blend of  claim 64  wherein probiotic a bacteria.  
     
     
         66 . A the method of making an extended release dosage comprising: 
 desiccating at least one of the group consisting of a release modifying agent, electrolyte, and a hydrophilic agent;    adding the desiccated material to a biologic, whereby a reduction in the available water content of the dosage is produced.